A Double-Blind Phase 3 Extension Trial Assessing the Long Term Safety and Efficacy of Glepaglutide in Patients with Short Bowel Syndrome (SBS)

Phase 3

Recruiting

• Conditions: Short Bowel Syndrome; 10025477

• Registration Number: NL-OMON55754
• Lead Sponsor: Zealand Pharma A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 10

Inclusion Criteria

Patients rolling over from the lead-in trial:
The patient must meet all of the following inclusion criteria:
1) Signed informed consent
2) Either of the following:
a) Completed the full Treatment Phase of the lead-in trial (ZP1848-17111),
regardless of treatment adherence.
OR
b) Eligible based on the same inclusion/exclusion criteria as in the lead-in
trial (patients may be directly screened into this trial)

Patients screened directly to the Extension Trial:
The patient must meet all of the following inclusion criteria:
1. Informed consent obtained before any trial-related activity.
2. Age >= 18 years and <= 90 years at Screening.
3. Diagnosis of SBS defined as remaining small bowel in continuity of estimated
less than 200 cm [equal to 79 inches] and with the latest intestinal resection
being at least 6 months prior to Screening and considered stable with regard to
PS need. No restorative surgery planned in the trial period.
4. Requiring PS at least 3 days per week.
5. Willing to adhere to an individual pre-defined drinking menu during 48-hours
measuring intervals.
6. Willing to maintain a stable weight (± 5%) for the duration of the trial (24
weeks).
7. Having:
a. A stoma Or
b. Colon-in-Continuity (CiC) with documented colonoscopy performed during
Screening and which does not give rise to any safety concerns.
Note: A colonoscopy performed within 6 months prior to Screening and not giving
rise to any safety concerns is acceptable. For patients with a remnant colon,
which is not connected to the passage of foods and is thereby dormant, a
computerized tomography (CT) scan or magnetic resonance imaging (MRI) (if
standard of care at site) will suffice at the discretion of the Investigator.
8. Having:
a) a stoma Or
b) colon-in-continuity (CiC) and able to separate stool and urine during the
48 hours measuring intervals.

Exclusion Criteria

Patients rolling over from the lead-in trial:
The patient must be excluded from this trial if any of the following criteria
are met:
1) Withdrew consent from lead-in trial.
2) Any condition, disease, or circumstance that in the Investigator's opinion
would put the patient at any undue risk, prevent completion of the trial, or
confounds planned assessments of the trial.
3) Use of GLP-1, GLP-2, human growth hormone (HGH), dipeptidyl peptidase-4
(DPP-4) inhibitors, citrulline, somatostatin, or analogs thereof within 3
months. Note: Prior glepaglutide trial drug is allowed.
4) Females of childbearing potential, who are pregnant, breast-feeding, intend
to become pregnant, or are not using highly effective contraceptive methods.
Highly effective contraception methods and definition of child-bearing
potential are described in Section 11.4.4 of there Study Protocol.
5) Committed to an institution by virtue of an order issued either by the
judicial or the administrative authorities.
6) An employee of the sponsor or Investigator or otherwise dependent on them.

Patients screened directly to the Extension Trial:
The patient must be excluded from the trial if he or she meets any of the
following criteria:
1. More than 2 SBS-related or PS-related hospitalizations (e.g., catheter
related bacteremia/sepsis, bowel obstruction, severe water-electrolytes
disturbances, etc.) within 6 months prior to Screening.
2. Poorly controlled inflammatory bowel disease (IBD) that is moderately or
severely active or fistula interfering with measurements or examinations
required in the trial.
3. Bowel obstruction.
4. Known radiation enteritis or significant villous atrophy, e.g., due to
active celiac disease.
5.Cardiac disease defined as: decompensated heart failure (New York Heart
Association [NYHA] Class III-IV), unstable angina pectoris, and.
6. Clinically significant abnormal ECG as judged by the Investigator.
7. Repeated (2 or more consecutive measurements separated by at least 15
minutes) systolic blood pressure measurements > 180 mm Hg.
8. Human immunodeficiency virus (HIV) positive, acute liver disease, or
unstable chronic liver disease.
9. Any history of colon cancer. History of any other cancers (except
margin-free resected cutaneous basal or squamous cell carcinoma or adequately
treated in situ cervical cancer) unless disease-free state for at least 5 years.
10. Estimated creatinine clearance (CrCL; by the Cockcroft-Gault formula) < 30
mL/min.
11. Hepatic impairment defined as:
a. Total bilirubin >= 2 × the upper limit of normal (ULN), or
b. Aspartate aminotransferase (AST) >= 5 × ULN, or
c. Alanine aminotransferase (ALT) >= 5× ULN
12. Use of GLP-1, GLP-2, HGH, somatostatin, or analogs thereof, within 3 months
prior to Screening.
13. Use of DPP-4 inhibitors within 3 months prior to Screening.
14. Systemic immunosuppressive therapy that has been introduced or has been
unstable within 3 months prior to Screening.
15. Unstable biological therapy (e.g. anti-tumor necrosis factor alpha [TNF-a],
natalizumab, etc.) within 6 months prior to Screening, including significant
changes in doses or switch of drug.
16. Females of childbearing potential, who are pregnant, breastfeeding, intend
to become pregnant or are not using highly effective contraceptive methods.
Highly

Study & Design

• Study Type: Interventional
• Study Design: Not specified